Catheter-Based Purse String Device for Mitral Valve Remodeling
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Solution Overview
Problem
Existing surgical techniques for remodeling soft tissue, particularly in heart valves, are invasive, leave foreign materials in the body, and often fail to effectively address issues like mitral regurgitation due to difficulties in adjusting the attachment of chords to the left ventricle relative to the valve annulus.
Innovation Solution
A minimally invasive catheter-based system using a purse string device with tissue anchors to remodel soft tissue structures, allowing for the adjustment of chord attachment points without leaving significant foreign objects in the body, thereby improving valve function and reducing regurgitation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical techniques are used to remodel soft tissue, then effective tissue remodeling can be achieved, but the procedure becomes invasive and leaves foreign materials in the body
Solution Approach 1:
The patent uses a catheter as an intermediary device to deliver the purse string mechanism through minimally invasive access. The catheter enables the implantation of tissue anchors and purse string without requiring open surgical incisions, thus achieving effective tissue remodeling while avoiding the harmful effects of invasive surgery and leaving minimal foreign material in the body.
Solution Approach 2:
The purse string device utilizes a flexible suture or elastic member that can be cinched to draw tissue anchors together. This flexible mechanism allows for effective tissue remodeling through a minimally invasive catheter-based approach, avoiding the need for rigid surgical instruments and large incisions.
2Ease of operation
If minimally invasive methods with stents, umbrellas, disks, plugs or rods are used, then access is improved, but devices remain in the blood pathway promoting thrombus formation
Solution Approach 1:
The purse string device is designed to be fully implanted within the tissue wall, with the cinching mechanism contained inside the tissue structure. The only permanent foreign material is the small tissue anchors embedded in the tissue, while the catheter and delivery system are completely removed after deployment. This eliminates the need for large devices remaining in the blood pathway.
Solution Approach 2:
The harmful catheter and delivery components are extracted from the body after deployment, leaving only the necessary tissue anchors embedded in the tissue wall. This extraction of unnecessary foreign material eliminates the thrombus formation risk associated with devices like stents and umbrellas that remain in contact with the blood pathway.
3Reliability
If devices attach valve leaflets together to reduce regurgitation, then regurgitation is reduced, but tears in the leaflets may occur requiring further surgery
Solution Approach 1:
The patent uses multiple separate tissue anchors distributed around the annulus rather than a single attachment point. This segmentation distributes the mechanical stress across multiple locations, preventing concentrated forces that could tear the leaflets. The anchors are embedded in the tissue wall at spaced intervals, creating a distributed attachment system.
Solution Approach 2:
The tissue anchors are embedded in the tissue wall beforehand to create cushioning points that distribute mechanical loads. The purse string mechanism gradually cinches the anchors together, allowing the tissue to adapt and preventing sudden stress concentrations that could cause leaflet tears.
4Manufacturing precision
If tight annuloplasty rings are used to buckle leaflets, then annular diameter is fixed, but mitral stenosis results and long term results degenerate
Solution Approach 1:
The purse string device provides dynamic adjustability of the annular diameter through the cinching mechanism. The suture or elastic member can be gradually tightened to achieve the desired annular size, and the system allows for fine-tuning of the configuration. This dynamic control prevents the fixed, overly tight configuration that causes mitral stenosis while maintaining long term flexibility.
Solution Approach 2:
The patent enables parameter changes in the annular configuration by adjusting the purse string tension and anchor positioning. The system can be tuned to achieve optimal annular diameter and leaflet coaptation parameters, avoiding the fixed parameter constraint of traditional annuloplasty rings that leads to mitral stenosis and long term degeneration.
Data Source
AI summary
Methods and systems for closing an opening or defect in tissue, closing a lumen or tubular structure, cinching or remodeling a cavity or repairing a valve preferably utilizing a purse string or elastic device. The preferred devices and methods are directed toward catheter-based percutaneous, transvascular techniques used to facilitate placement of the devices within lumens, such as blood vessels, or on or within the heart to perform structural defect repair, such as valvular or ventricular remodeling. In some methods, the catheter is positioned within the right ventricle, wherein the myocardial wall or left ventricle may be accessed through the septal wall to position a device configured to permit reshaping of the ventricle. The device may include a line or a plurality of anchors interconnected by a line. In one arrangement, the line is a coiled member.